Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

Yuan Zhang, Lei Chen, Guo Qing Hu, Ning Zhang, Xiao Dong Zhu, Kun Yu Yang, Feng Jin, Mei Shi, Yu Pei Chen, Wei Han Hu, Zhi Bin Cheng, Si Yang Wang, Ye Tian, Xi Cheng Wang, Yan Sun, Jin Gao Li, Wen Fei Li, Yu Hong Li, Yan Ping Mao, Guan Qun ZhouRui Sun, Xu Liu, Rui Guo, Guo Xian Long, Shao Qiang Liang, Ling Li, Jing Huang, Jin Hua Long, Jian Zang, Qiao Dan Liu, Li Zou, Qiong Fei Su, Bao Min Zheng, Yun Xiao, Ying Guo, Fei Han, Hao Yuan Mo, Jia Wei Lv, Xiao Jing Du, Cheng Xu, Na Liu, Ying Qin Li, Fang Yun Xie, Ying Sun, Jun Ma, Ling Long Tang

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Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P = .001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P = .005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P = .77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

Original languageEnglish
Pages (from-to)2420-2425
Number of pages6
JournalJournal of Clinical Oncology
Volume40
Issue number22
DOIs
StatePublished - Aug 1 2022
Externally publishedYes

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